Integra LifeSciences I Ltd. v. Merck KGaA

Case Number: CLB0169

Date: 07.27.2007

Citation: 83 U.S.P.Q.2d 1673 (Fed. Cir. 2007)

Preclinical research that is not included in an FDA submission can be exempt from patent infringement under 35 U.S.C. § 271(e)(1) if the drug maker has a reasonable basis for believing that the research, if successful, would be appropriate to include in an FDA submission.

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